Unregistered and compounded Schedule 8 medicines

​​​​​​​​​​​​​​​​​​Unregistered medicines

Unregistered medicines are medicines that are not included in the Australian Register of Therapeutic Goods (ARTG)​​​​They are not assessed for quality, safety or efficacy by the Therapeutic Goods Administration (TGA). ​
Unregistered medicines include those that are compounded.​​

​Prescribing or supplying unregistered or compounded Schedule 8 medicines

​Commonwealth requirements

​​​To prescribe or supply any unregistered scheduled medicine, a prescriber must obtain an approval under the Commonwealth’s Therapeutic Goods Act 1989 using one of the following pathways:

• Special Access Scheme (SAS), or
  
• Authorised Prescriber Scheme (AP), or
• Clinical Trial Schemes.

For further information visit the TGA websi​​​​​​te​​​.​

Schedule 8 medicines that are extemporaneously compounded for a particular person for therapeutic application to that person are exempted from registration on the ARTG and from requiring TGA approval. However, in NSW, a prescriber must obtain approval from NSW Ministry of Health to prescribe or supply any extemporaneously compounded Schedule 8 medicine.​

​NSW Ministry of Health requirements

Under the NSW Poisons and Therapeutic Goods Act 1966, an approval is required to prescribe or supply an unregistered Schedule 8 medicine:

• to a drug dependent person*
• that is a compounded medicine, or
• for a clinical trial.

* A drug dependent person defined under section 27 of the Poisons and Therapeutic Goods Act 1966 (NSW) means a person who has acquired, as a result of repeated administration of: ​

• a drug of addiction, or
• ​​a prohibited drug (as defined in the Drug Misuse and Trafficking Act 1985),

​an overpowering desire for the continued administration of such a dr​ug.

​How to apply for an approval 

To apply for an approval to prescribe or supply an unregistered or compounded Schedule 8 medicine in NSW,  a prescriber is required to complete and submit an  Application for Authority to Prescribe or Supply an Unregistered or (Pharmacy) Extemporaneously-Compounded Schedule 8 Product for Human Therapeutic Use. 

Only medical practitioners can apply for an approval to prescribe or supply a compounded Schedule 8 medicine. The approval number issued to the medical prescriber must be included on the prescription for it to be valid for dispensing.

A pharmacist cannot dispense a prescription for a Schedule 8 compounded medicine if the approval number issued by NSW Ministry of Health is not included on the prescription. 

​Dispensing unregistered Schedule 8 medicines

The following apply to dispensing unregistered and extemporaneously compounded Schedule 8 medicines:​

• ​Prescriptions: A pharmacist can only dispense or extemporaneously​ compound these medicines if they have a valid prescription. Supply on a telephone, fax or email order is not permitted.
• Hospitals using the Pharmaceutical Benefits Scheme Hospital Medication Chart prescription as per the Commonwealth and NSW requirements for the PBS HMC, may provide the duplicate copy of ​the medication chart for supply by the contracted pharmacy.
• Approval numbers: Prescriptions for an extemporaneously​ compounded Schedule 8 medicine must include the NSW approval number issued to the prescriber (which has the format "AXXXXXXX" where X is a numeral).
• ​Prescription verification: A pharmacist must ensure the prescription meets all Schedule 8 prescription requirements as well as ensure that they know the patient, or the prescriber, or independently verify that the prescription is valid with the prescriber. 
• Record keeping: All transactions for that medicine must be recorded in a drug register on the day of that transaction. The dispensed prescription must be retained separately from other prescriptions (except those listed in Schedule 4 Appendix B).​
• Labelling: All Schedule 8 medicines supplied to a patient by a pharmacist or prescriber must be labelled with a dispensing label with the usual details as for any dispensed Schedule 8 medicine. 
• Wholesale supply of pharmacy-compounded medicines is not permitted.​
• ​Storage: They must be stored with other Schedule 8 medicines, separately and securely in a safe. For refrigerated preparations, see Storage of a Schedule 8 medicine requiring refrigeration​.

Approval exceptions​​​​​​​​​

​An approval to prescribe or supply an unregistered Schedule 8 medicine is not required in the following circumstances:

• Prescribers with an existing NSW approval for a Schedule 8 medicine (such as a psychostimulant medicine) that request to prescribe or supply the approved medicine as a compounded preparation.
• Schedule 8 manufactured medicines when manufactured under a contract with a public or private hospital or institution, according to a formulation specified by the facility for its patients. The following conditions apply: 
• ​​​​no similar listed or registered medicine exists
• the substance must be manufactured in Australia by a licensed​​​​ manufacturer under the Therapeutic Goods Act 1989
• the manufacturer must notify the Commonwealth Secretary of Health quarterly about the substances manufactured.

• ​Compounded Schedule 8 medicines:
• ​When compounded by a pharmacist in a public hospital pharmacy for patients of that hospital.
• When compounded by a pharmacist in a facility licensed under the Private Health Facilities Act 2007 for patients receiving:
• ​chemotherapy (parenteral cytotoxic agents)
• emergency treatments for accident-related injuries or medical emergencies
• neonatal treatment for infants under 28 days old 
• palliative care medical services
• surgical procedures involving general or major regional anaesthesia. This excludes surgical procedures by a dentist.

• ​​​Topical cocaine: Compounded by a pharmacist for topical application to patients in a facility licensed under the Private Health Facilities Act 2007.